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Northern Ireland Cancer

Clinical Trials Unit

Centre for Cancer
Research and Cell
NICCTU based in
the Clinical Cancer
n i c c t u
CCRCB structure 2
Foreword 3
Staff Listing 4
Introduction 5
Trial Administration and Management 12
Clinical Research Nursing 13
Clinical Research Therapy Radiographers 16
Data Management 17
Hospital Services 19
Research Areas 21
Trials Portfolio 36
Publications 49
Acknowledgements 53
CehIre !or Cahcer Research & Cell 8iology

Medicinal Chemistry/
Drug Development
Research Divison
Cancer Cell & Molecular
Biology Research Divison
Experimental Cancer Medicine
Research Divison

1rahslaIiohal Research
Clihical Research Fellows NICC1U
Clihical Cahcer CehIre
Centre For Cancer Research And Cell Biology
The Centre for Cancer Research and Cell Biology (CCRCB)
was formally established in 2004 at Queens University Belfast
(QUB) through the amalgamation of basic science and clinical
research teams with common interests in cancer cell biology,
medicinal chemistry, tumour pathogenesis and clinical and
translational research. Our aim was to create an international
Centre of Excellence promoting high quality basic and
translational clinical research with a broad base of funding
and support from Cancer Research UK (Cancer Research
UK), Department of Health, Social Services and Public Safety
(DHSSPS), Medical Research Council (MRC), Biotechnology and
Biological Sciences Research Council (BBSRC), Wellcome Trust,
Leukaemia Research Fund and Ulster Cancer Foundation.
The Centre is one of the largest research entities in the UK and
fully integrates basic science, translational and clinical research
within the University and NHS academic setting. There are 34
Principal Investigators and over 300 researchers and newly
appointed staff within the Centre which provides a foundation
model for future research in cancer at QUB. The development
of this Centre ensures that Northern Ireland contributes in
a strategically important way in future UK and international
research initiatives in cancer, as well as in medicinal chemistry
and drug development.
One of the major components of the Centre is the Northern
Ireland Clinical Trials Unit (NICCTU) which is part of the
Experimental Cancer Medicine Research Division within
CCRCB. NICCTU helps drive clinical trial development
from Phase I through Phase IV studies and also spearheads
the development of translational research as part of the
Northern Ireland Experimental Cancer Medicine Centre
funded by Cancer Research UK and the DHSSPS Research and
Development Offce. Over the last few years, various basic
scientifc research projects stemming from our laboratories
have begun to be translated towards practical therapies. A
number of other studies, including frst in human clinical
trials, related to basic science research activities within CCRCB
are now being actively carried out within NICCTU. The close
proximity of the CCRCB building to the new Northern Ireland
Cancer Centre on the Belfast City Hospital (BCH) campus has
offered a unique opportunity to link our basic, translational
and clinical research programmes as part of the development
of our comprehensive cancer centre. Moreover, these
developments have also provided a modern state-of-the-art
clinical facility devoted to the diagnosis and treatment of
cancer and to education of health care professionals in cancer
and have also facilitated the enrolment and performance of
clinical trials. We envisage that this process will continue to
accelerate and further develop and enhance our ability to
develop novel therapeutic and diagnostic approaches resulting
in better treatment of cancer.
We hope you very much enjoy fnding out more about our
clinical trials and translational research programmes in N.
Patrick Johnston
Dean of School
of Medicine and
Dentistry, Director
of the Institute of
Health Sciences,
Queens University
Dennis McCance
Scientifc Director
n i c c t u
NICCTU Executive Committee
Clinical Director: Dr Richard Wilson
Operational Director: Dr Melanie Morris
Deputy Directors: Ms Ruth Boyd,
Dr Seamus McAleer, Professor Mary
Francis McMullin, Dr Joe OSullivan
Trial Management and
Operational Director: Dr Melanie Morris
Team: Mrs Joanne McAllister, Mr Jim
ONeill, Mr Jonathan Thompson and Mrs
Debbie Williams
Data Management
Senior Manager: Mrs Angela Morrison
Team: Ms Helen Burnett, Ms Alison
Clarke, Mr Peter Clarke, Ms Emma
Gibson, Mrs Bronagh McClory and Mrs
Kathleen Mason
Clinical Research Nursing
Cancer Research UK Senior Nurse:
Ms Ruth Boyd
Lead Clinical Research Nurse / Network
Manager NICCTU and NICTN:
Mrs Eileen Dillon
Early Clinical Trials Team:
Ms Mairead Devine, Mrs Diane Law,
Ms Joanne Todd
Haematology Team:
Mrs Caroline Kerr, Mrs Tracey
McGuigan, Ms Lorraine McKenna
Oncology Team:
Mrs Tracey Burns, Ms Rachel Convery,
Ms Wendy Cunningham, Mrs Barbara
Harvey, Ms Sharon Kerr, Ms Sara Stokes,
Ms Naomi Hill, Mrs Alison Maghie
Paediatric Team:
Ms Valerie Wallace, Ms Sinead Gallagher
Screening Team:
Ms Adrina ODonnell, Mrs Margaret
Palliative Care:
Ms Ashlene McCurry
Clinical Research Therapy
Lead Clinical Research Therapy
Mrs Sharon Hynds
Clinical Research Therapy Radiographer:
Ms Stacey Early
Clinical Trials Pharmacist: Mrs Linda
McNeice (2nd post to be appointed)
Clinical Trials Pharmacy Technician:
Mrs Angela Rosbotham
Research Radiology Co-Ordinator:
Mrs Miranda Reid
Post Doctoral Research Fellow:
Dr Rebecca Gallagher
Tissue Procurement Technician:
Mr Conal Askin
Network Clinical Research Nurses:
Altnagelvin Hospital:
Ms Caroline Oates; NICTN post to
be appointed
Antrim Area Hospital:
Mrs Aishleen Cunningham
Craigavon Area Hospital:
Ms Ruth Hall
Ulster Hospital:
Ms Ethna McFerran
n i c c t u
Staff Listing
Introduction to the Northern Ireland Cancer Clinical
Trials Unit
Our mission at NICCTU is to deliver the highest quality and
standard of care to cancer patients through leading edge
clinical and translational research.
To ensure high quality patient care by participation in clinical
To co-ordinate and promote cancer clinical trial activity
throughout Northern Ireland
To attain full UKCRC accreditation and NCRI registration as
a national cancer clinical trials unit co-ordinating single and
multi-centre trials throughout the UK and Ireland
To drive the development of early phase cancer clinical trials
To integrate with Queens University Belfast and University of
Ulster basic science and translational research programmes
To develop and train clinical research staff
The NICCTU was formally established in 1999 following
the signing of the NCI-Ireland-Northern Ireland Cancer
Agreement. Our local DHSSPS Research and Development
Offce (R&DO) provided funding for the initial infrastructure
to be put in place. Today R&DO provides core funding in
support of the NICCTUs continued expansion with signifcant
additional funding being provided by several Cancer Research
UK grants and from local charities such as Friends of the
Cancer Centre.
The NICCTU was primarily set up to co-ordinate and promote
cancer clinical trials, and currently runs the full range of
frst-in-human phase I to phase IV trials, along with genetic
epidemiology, questionnaire, quality of life and other studies.
Clinical trials can be designed locally (investigator-initiated) or
adopted as part of a multi-centre study. Investigator-initiated
trials often involve collaboration with other academic groups
within local universities or hospitals. Alternatively national
and international collaborations involve Cancer Research
UK (Cancer Research UK), the National Cancer Research
Network (NCRN), Medical Research Council (MRC), European
Organisation for the Research and Treatment of Cancer
(EORTC), All-Ireland Co-operative Oncology Research Group
(ICORG), the US National Cancer Institute (NCI), US co-
operative groups and a variety of companies involved in the
biotechnology and pharmaceutical industries.
In recent times the NICCTUs role has expanded to include:
(i) that of the Northern Ireland Cancer Trials Network (NICTN)
responsible for the co-ordination of cancer clinical trial
activity throughout N. Ireland, particularly phase III trials
and epidemiology studies; and (ii) that of an academic early
clinical trials unit running a portfolio of Cancer Research UK,
commercial and local investigator-initiated phase I, II and
translational trials. In April 2007 the NICCTU and CCRCB were
awarded Experimental Cancer Medicine Centre (ECMC) status,
one of 17 such centres appointed within the UK.
n i c c t u
Dr Richard Wilson
Clinical Director of
Location and Facilities
The NICCTU is housed in the Cancer Centre (CC) located at
Belfast City Hospital (BCH) and is also part of the Queens
University Belfast (QUB) Centre for Cancer Research and Cell
Biology (CCRCB). The current facilities for clinical research
in BCH include space for clinical research within the existing
40 bed day hospital for cancer patients, and in-patient beds
for patients on research protocols are provided in wards in
the Cancer Centre and in the Royal Belfast Hospital for Sick
Children (RBHSC). The clinical trials effort has dedicated
pharmacy support and chemotherapy reconstitution
facilities alongside the existing NHS facilities. These facilities
are supported by a Clinical Pharmacology laboratory for
sample processing and storage for pharmacokinetic,
pharmacodynamic and pharmacogenetic studies. In addition,
the NICCTU is supported by a dedicated clinical trials radiology
service within the radiology department at BCH.
Trials Portfolio and Recruitment
There are on average 50 - 60 clinical trials open for accrual at
any time (see Trials Portfolio P37). In adults, we concentrate
on cancers of the gastrointestinal and genitourinary tracts,
lung, breast, gynae, haematological malignancies and
cancer screening. Paediatric phase II and III solid tumour and
haematological trials take place in the RBHSC.
NICCTU studies are run by a team of consultant medical,
clinical, haematological, surgical and paediatric oncologists
supported by an operational director, clinical research
nurses, clinical research radiographers, data managers and
administrative staff. NICCTU currently recruits approximately
700 patients (8.2% of incident cancers excluding non-
melanoma skin cancers) annually to clinical trials. The goal is to
increase this number to meet national UK targets of 10% by
Organisation and Management
The NICCTU is part of the Experimental Cancer Medicine
Research Division of CCRCB at QUB and the Cancer Centre
in the Belfast HSC Trust. Overall unit management is the
responsibility of the Clinical Director of the NICCTU, with daily
activities being managed by the Operational Director. Portfolio
management, strategic direction and business matters are
the responsibility of the Executive Committee. The Executive
Committee comprises the Clinical Director, the Operational
Director and 4 Deputy Directors (Cancer Research UK Senior
Research Nurse, 2 Consultant Oncologists/Senior Lectures and
a Consultant Haematologist/Professor). The NICCTU Executive
reports to the Director of the Institute of Health Sciences at
QUB and to Belfast HSC Trust leadership through the Associate
Medical Director for Research.
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Organisational Structure of NICCTU
* LxecuIive CommiIIee
Deputy Director * Operational Director *
Clinical Director * Senior Lecturer / Consultant Oncologist
Lead Clinical Research Nurse/
Network Manager
CT Practitioners
(3.0 WTE)
Admin Clerk
(1.0 WTE)
Lead Research Therapy
(1.0 WTE)
Senior Data Manager
(0.6 WTE)
Data Managers
(4.6 WTE)
Data Clerk
(1.0 WTE)
Research Therapy
(1.0 WTE)
Clinical Trials Pharmacist (1.5 WTE)
Clinical Trials Pharmacy Technician (0.6 WTE)
Tissue Procurement Technician (1.0 WTE)
Clinical Trials Radiology Co-Ordinator (0.2 WTE)
Consultant Radiology & Pathology Sessions
Post Doctoral Research Fellow

Nurses (13.4 WTE)
(5.0 WTE)
2x Senior Lecturers /
Consultant Oncologists *
1 Professor /
Consultant Haematologist
Cancer Research UK
Senior Research Nurse
The Units activities are subdivided and managed by a number
of teams that report to the Executive Committee:
(i) Administration Team
Responsible for trial set-up (including ethical approval
and research governance), offce management, fnancial
management and general administration.
(ii) Data Management Team
Responsible for source data collection, primary data entry, case
report form and database design, query resolution and liaising
with trial monitors.
(iii) Clinical Research Nursing Team
Responsible for the co-ordination and delivery of oncology/
haematology, cancer screening or early phase clinical trials and
patient care for adults and children throughout the trial. Each
research nurse acts as a primary or associate nurse co-ordinator
for a number of studies within a designated area of interest.
(iv) Clinical Research Therapy Radiography Team
Responsible for the co-ordination and delivery of radiotherapy
trials, including patient recruitment, treatment planning and
(v) Hospital Services
Dedicated resource within the Pharmacy, Radiology and
Pathology departments to facilitate cancer clinical trial activity
is funded by NICCTU held grants.
n i c c t u
NICCTU Executive Committee
(left to right) Ms Ruth Boyd, Dr Joe OSullivan, Dr Melanie Morris, Professor Mary Frances McMullin,
Dr Seamus McAleer, Dr Richard Wilson
Education and Training
The NICCTU has a well established training programme.
All staff take part in an induction programme which includes
an introduction to the units policies and procedures, periods
of work shadowing to understand different roles within the
organisation and attendance at relevant external training
courses depending on experience.
The NICCTU ensures that all trials staff are regularly trained
and updated on Good Clinical Practice (GCP), research
governance, EU Clinical Trials Regulations, the Human Tissue
Act, informed consent, trial/cancer site specifc training and
relevant NCRN, ECMC and NHS courses. GCP training is
mandated biannually. Additional e-learning GCP programmes
are also provided through participation in certain externally
sponsored trials. Clinical research nurses have the opportunity
to attend a research nurse training programme at the National
Cancer Institute (NCI) in the USA. Further informal internal
education sessions are provided by senior staff and by staff
returning from external courses and conferences. Additional
training and development for staff is gained through links with
the Pharmaceutical Industry.
NICCTU staff also have access to the Queens University
(QUB) academic seminar series and Beeches Management
development programmes. In conjunction with the NCI/
All-Ireland Nurses Working Group and QUB an accredited
e-learning clinical trials module for research staff has been
n i c c t u
n i c c t u
Northern Ireland Cancer Trials Network
The NICCTU accrues patients into trials from throughout N.
Ireland, but all activities have until recently been based in the
N. Ireland Cancer Centre within the Belfast HSC Trust. This
currently includes the Belfast City Hospital (BCH) and the Royal
Group of Hospitals which comprises the Royal Victoria Hospital
(RVH) and the Royal Belfast Hospital for Sick Children (RBHSC).
To facilitate equitable and convenient access to clinical trials
for cancer patients from throughout N. Ireland, Cancer
Research UK and R&DO have jointly funded the formation
of the Northern Ireland Clinical Trials Network (NICTN). This
funding has enabled the NICCTU to appoint dedicated clinical
research nurses to support cancer trial activity at each of the
four Cancer Units (Altnagelvin Hospital, Antrim Area Hospital,
Craigavon Area Hospital and Ulster Hospital Dundonald). This
has also allowed us to increase our support for paediatric and
other clinical trials at the Royal Group of Hospitals. Not only
will this bring equity of access to patients throughout the
province, but will also increase clinical trial capacity, activity
and ultimately the number of patients accrued into clinical
trials conducted within N. Ireland.
NICCTU as a Cancer Clinical Trials Unit
The NICCTU aims to develop its function as a cancer clinical
trials unit by increasing its capacity to conduct high-quality
clinical trials that will include and promote translational
research. The NICCTU, in collaboration with the N. Ireland
Clinical Research Support Centre (CRSC) based at the RVH,
has already been awarded provisional registration as a UK
Clinical Research Collaborative CTU and will aim to gain NCRI
accreditation in the near future.
Whilst the NICCTU offers strengths in the set up and conduct
of trials in a clinical setting, CRSC offers generic statistical
and data management support and acts as the Statistics and
Data Management Offce (SDMO) for All-Ireland Cooperative
Oncology Research Group. CRSC has also established a
regional monitoring group which NICCTU utilises to ensure
quality control of Belfast Health & Social Care Trust sponsored
investigator-initiated trials.
Northern Ireland Cancer Clinical Trials Coordinating
New trials are reviewed at the monthly multi-professional
Northern Ireland Cancer Clinical Trials Coordinating
Committee which is attended by health care professionals in
all key disciplines. Potential trials are reviewed with respect
to scientifc and clinical merit, deliverability and local interest.
Ongoing trials are regularly reviewed as regards accrual, new
developments and challenges.
Trials are split into disease site, modality or phase specifc
multi-professional teams:

Breast Cancer, Early Clinical Trials (including Translational
Research), Gastro-intestinal Cancer (Upper and Lower),
Genito-urinary Cancer (including Testicular Cancer),
Gynaecological Cancer, Haematology, Lung Cancer (including
Mesothelioma), Miscellaneous (including Melanoma, Palliative
and Supportive Care), Paediatric Cancer, Radiotherapy and
n i c c t u
The last few years have seen a number of legislative changes
that have led to a signifcant increase in the administrative
burden associated with conducting clinical trials. These
include the introduction of NHS Research Governance, the
European Union Clinical Trials Directive and the Human
Tissue Act. Consequently the NICCTU has appointed a
dedicated Administrative Team to ensure that all the necessary
documentation is in place prior to opening a trial, during
its conduct and following trial closure. The current team
comprises 3 Clinical Trial Practitioners (CTPs) responsible
for ethics, regulatory authority and research governance
applications. CTPs also act as a primary point of contact for
trial sponsors and their representatives. An Administrative
Clerk provides offce support for all NICCTU staff. The whole
team is supervised by the Operational Director of the NICCTU
who is also responsible for contract, budget and resource
management. In addition to trial set-up and governance,
the Administrative Team acts as an information source with
regards to recruitment status, trial portfolio content and new
trial information. The Administrative Team works closely with
all 5 Health and Social Care Trusts.
Standard Operating Procedures
The NICCTU has developed a set of Standard Operating
Procedures (SOPs) that cover all aspects of trial conduct and
ensures trials are compliant with ICH-GCP, the EU Clinical Trials
Directive, local Trust policies and other applicable regulations.
The SOPs provide step by step instructions on how to perform
particular procedures and ensure a consistent approach by all
staff. NICCTU SOPs are developed under the management
of a multi-professional SOP Task Force. This team ensures the
identifcation, writing and review of new SOPs whilst policing
the adherence and revision of current SOPs. SOPs are defned
for each department (Data Management, Trial Administration
and Management, Nursing etc). The team leader for each
department and/or a member of staff who is responsible for
this process is then tasked with writing the working procedure.
The author is responsible for ensuring that all information
documented is accurate, refects current practice and complies
with good clinical practice guidelines, regulatory and local
research governance requirements. A standard template has
been created which provides the recommended structure
and format for all NICCTU SOPs. The competency of staff to
carry out their delegated function is achieved and maintained
through a combination of induction, mentoring and course
attendance, all of which is formally recorded as required by
Trial Administration and Management
n i c c t u
Dr Melanie Morris
Operational Director
Clinical Trial Administration (left to right)
Dr Melanie Morris, Mr Jim ONeill,
Mrs Joanne McAllister, Mr Jonathan
Thompson & Mrs Debbie Williams (not pictured)
n i c c t u
The mission of Clinical Research Nurses (CRNs) in the
To support the practice and development of the cancer
clinical research programme throughout Northern Ireland
To provide specialised cancer nursing care to patients and
their families during clinical trials
To provide knowledgeable management of the clinical trial
protocol, effective communication and staff education
To work in a team to achieve high standards of patient care
and clinical outcomes
Team Organisation
The NICCTU has a strong team of CRNs which continues
to expand and develop. Currently there are a total of 24
posts who support the full portfolio of trials co-ordinated by
the NICCTU and NICTN. Within the NICCTU each research
nurse acts as a primary or associate nurse co-ordinator for a
number of studies within a designated area of interest, such
as cancer screening, early phase trials, paediatric cancers, or
studies in gastro-intestinal, breast, genito-urinary, melanoma
and gynaecological cancers, leukaemia, lymphoma and
multiple myeloma, pre-malignant conditions and palliative and
supportive therapies across a variety of cancer types. Within
the NICTN each CRN is the co-ordinator and data manager for
a portfolio of trials in the common cancers and haematological
cancers treated at the Cancer Units.
Integration and Involvement
The care and delivery of cancer clinical trials is fully integrated
into the cancer services provided by the Belfast, Northern,
South Eastern, Southern and Western HSC Trusts. CRNs work
closely with the other members of their profession and the
Multi-professional Teams. For example, CRNs work across
Oncology/Haematology within the Specialist Services Group
of Belfast HSCT, and other wards and departments within
the hospital. Link nurses within the clinical areas liaise with
the CRNs and education sessions precede the introduction
of new trials. CRNs also have a designated link nurse role to
ensure maintenance of nursing regulations and mandatory
competence and education. CRNs also have involvement in the
following: Various groups within N. Ireland Cancer Network,
CCRCB, Cancer Recognised Research Group, Experimental
Cancer Medicine Centres Network, National Cancer Institute
All-Ireland Nurses Working Group, QUB School of Nursing and
Midwifery, CRSC and ICORG.
Education, Development and NCI links
CRNs are experienced cancer nurses and an initial focus in
their development is expanding clinical research skills and
knowledge. GCP training is supplemented by an induction
and development programme. CRNs also support the
education of post-registration nursing staff through induction
programmes to Oncology/Haematology, lectures on the
biomedical modules of Specialist Practice and Administration
of Chemotherapy, Breast, Gynaelogical and Haematological
Cancer Modules. In response to the expanding number and
Clinical Research Nursing
Ms Ruth Boyd
Cancer Research UK
Senior Nurse
Clinical Research Nursing
n i c c t u
increasing geographic spread of cancer clinical research nurses
in Ireland, the NCI/All-Ireland Nurses Working Group proposed
that an e-learning approach would help facilitate the need for
continuing accredited education specifc to clinical research
nursing. Queens University Belfast (QUB) offers a stand alone
module in Clinical Trials developed by Dr Fiona Alderdice.
Following a consultation process it was agreed adopting an
e-learning approach for the existing module was the ideal
way to proceed. Many available courses primarily focus on the
design and analysis of trials which are helpful in writing your
own trial protocol. This course provides a different perspective.
While design and analysis are an important part of the course,
equal focus is given to the many issues that clinical research
nurses face in the day to day management of clinical trials.
Mrs Eileen Dillon
Lead Clinical Research
Nurse / Network
Manager, NICCTU and
Ms Ruth Boyd and Mrs Eileen Dillon
Clinical Research Nurses
Clinical Research Nurses
Clinical Research Nursing
n i c c t u
The module content includes: Clinical Trials and the hierarchy
of evidence, Clinical Trial Design and Management, Quality of
Life Assessment and other measures in Clinical Trials, Analysis
and Interpretion of Data, Pharmacotherapeutics, Ethical Issues
and Research Governance issues in Clinical Trials, and The
Consumer perspective and Developing a Research Career.
A further key strand of the training opportunities for CRNs
in NICCTU has been the opportunity to apply for Clinical
Trials Nursing Training at the National Cancer Institute. This
5 week training programme is co-ordinated by the NCI/All-
Ireland Nurses Working Group. The broad aim of the training
programme is to support and enhance recruitment to cancer
clinical trials across Ireland and N. Ireland. This is achieved by
developing a skilled research workforce through increasing
nurses knowledge and experience in clinical research,
and providing an on-going opportunity for networking
and collaboration. Within this context, the NCI offers each
participant a tailor-made learning experience based around
their learning objectives. Within the programme, the available
resources and expertise at the NCI are utilised, including a
series of lectures on the Ethical and Regulatory Aspects of
Human Subject Research. All aspects of the clinical trial life-
cycle, roles, processes and procedures can be explored, and
placements on research wards and clinics are available across
a range of cancers and various treatment modalities. During
this unique opportunity at the NCI, participants are based in
the National Institutes of Health Clinical Centre, a bio-medical
research facility with over 300 beds.
The Cancer Research UK Senior Nurse promotes the work
of Cancer Research UK and raises the profle of the charity
and the vital importance of clinical research. Responsibilities
include education and training, research, clinical and
professional development, providing science and clinical
research information at fundraising events, media, and
developing partnership working with the charity departments
and personnel as well as the wider clinical research community
nationally and internationally. The Cancer Research UK Senior
Nurse provides nursing leadership and is also involved in
the management and strategic direction of the NICCTU as a
member of the Executive Committee and Cancer Research
UK representation for the NICTN Steering Group. The Lead
Clinical Research Nurse/Network Manager, NICCTU and NICTN
has direct responsibility for the Clinical Research Nurse teams
and provides leadership utilising facilitative approaches to
promote Clinical Research Nurses practice development. This
role also has vital management responsibilities including staff
recruitment, induction, co-ordination, and workload capacity.
Management experience for the CRNs is maintained through a
team leader rotation programme.
n i c c t u
Mrs Sharon
Lead Clinical
Research Therapy
Ms Stacey Early
Clinical Research
Clinical Research Therapy Radiographers
Clinical Research Therapy Radiographers
Radiation oncology research is supported by the Lead Clinical
Research Therapy Radiographer, Sharon Hynds, who is
responsible for the management and co-ordination of all trials
involving radiation oncology. Sharon is actively involved in the
initial design and co-ordination of new radiation oncology
trials which are driven by radiotherapy departmental service
requirements. Sharon has recently been appointed onto
the National Cancer Research Institute (NCRI), Radiotherapy
Clinical Studies Group and regularly presents at local, national
and international meetings. Ms Stacey Early joined the NICCTU
as a Clinical Research Therapy Radiographer in 2007 to expand
capacity in our radiation oncology clinical research program.
Data Management
n i c c t u
Management Team
(from left to right)
Ms Alison Clarke,
Mr Jonathan
Mrs Angela Morrison,
Mr Peter Clarke,
Mrs Bronagh McClory,
Ms Emma Gibson,
Ms Helen Burnett &
Mrs Kathleen Mason
(not pictured)
The Data Management Team has a team of 7 dedicated staff
made up of a Senior Data Manager, 5 Data Managers and
a Data Clerk. The main function of the team is to provide
a Data Management Service to support the collection,
collation, dissemination and quality assurance of confdential
and sensitive data for patients who have been entered into
Haematology, Oncology and Radiotherapy Clinical Trials.
Each Data Manager is responsible for their own portfolio of
studies and is trained extensively on the protocols and data
collection required for each study. Data is collected from a
variety of source documents including, for example, patients
case notes and Hospital Clinical Information Systems. A variety
of data capture techniques are now also used to report this
information, including paper case report forms and electronic
data capture systems.
All trials require monitoring to ensure that the data is accurate,
up to date and verifable and that patients are treated in
accordance with an ethically approved protocol, to Good
Clinical Practice standards and in compliance with European
Clinical Trial regulations. Each Data Manager is responsible for
liaising with an external monitor acting on behalf of the trials
sponsor to resolve any data queries that may arise. The Clinical
Research Support Centre offers a regional monitoring service
for the Trust sponsored trials.
Mrs Angela
n i c c t u
The NICCTU is subject to audit and inspection by external
independent organizations, competent authorities and trial
sponsors. The resulting suggestions and recommendations
are discussed with the study team and actioned where
appropriate; the overall aim being to continually improve
the operational effciency of the unit. As a team, the
Data Managers work with very sensitive and confdential
information pertaining to patients participation in cancer
clinical trials. It is imperative that the team is well versed in
all legislation governing clinical trial conduct and continued
professional development is considered essential for the team.
The NICCTU believes that work should be of the highest
standard not only ensuring patient safety but enabling the
production of high quality data that can be used to make
informative decisions about treatment planning for future
Data Management
Hospital Services Supported by
NICCTU Funding
The pharmacy department in Belfast City Hospital consists of
the Main Pharmacy, located on the ground foor of the tower
block and the Satellite Pharmacy, located adjacent to the
Bridgewater Suite. Both pharmacies have areas dedicated to
clinical trial activity. The majority of clinical trial activity for the
Oncology / Haematology directorate is managed within the
Satellite Pharmacy which opened in 2003. It was designed,
built and resourced to meet the cancer chemotherapy
preparation requirements of the Haematology / Oncology
Directorate. Chemotherapy is prepared in compliance with
the requirements of The Medicines Act 1968 through the
application of specifc exemptions provided by section 10
The facility consists of fve modern cleanrooms providing
accommodation for up to eight type II negative-pressure
pharmaceutical isolators. One cleanroom with one isolator
(at present) has been designated and used for the preparation
of gene therapy. Pharmacy staff play a pivotal role in the
management of medicines used in the conduct of clinical
research and excellent Pharmaceutical Services are an
essential component of the clinical research infrastructure.
Pharmacy staff have a responsibility to the patient, and to
the Trust, to ensure that systems are sound, that patients
are protected, that research is being conducted safely and
that patient confdentiality is maintained. Cancer clinical
trials are supported by 1.5 WTE designated oncology
pharmacists (based in the Satellite Pharmacy) with part-
time dedicated support from a senior pharmacy technician
(based in the Main Pharmacy). The pharmacy is involved
in both commercially sponsored and in-house clinical
trials using both marketed products and investigational
medicinal products (IMPs). Pharmacy staff ensure the smooth
implementation of new trials by reviewing each protocol
and assessing the feasibility of the study, costing the work
to be undertaken by the pharmacy department and where
appropriate assessing the impact for the Trust. Pharmacy staff
assess all IMPs and provide advice on their source, quality,
acceptability, packaging, labeling and cost. They also ensure
the safe and proper management, procurement, handling,
storage, aseptic preparation, dispensing and use of IMPs in
accordance with the requirements of the trial protocol and
the relevant regulations and guidelines. All IMPs are stored
in and dispensed by the hospital pharmacy. Access to IMPs is
restricted to pharmacy personnel. It is anticipated that there
will be increasing demand for hazardous IMPs (eg. cytotoxic
chemotherapy, monoclonal antibodies, biologicals, vaccines,
gene therapy etc.) to be prepared in the Satellite Pharmacy
using negative-pressure isolator technology, regardless of the
speciality of the clinical research being undertaken.
Hospital Services
n i c c t u
The Radiology Directorate is actively involved in research. In
addition to research originating within the Directorate, many
clinical trials from all other Directorates within the Trust require
dedicated radiological input. To facilitate all research within the
directorate a dedicated post of Clinical Trial Co-ordinator was
created in 2003 and Ms Miranda Reid was recruited to this
vital position. A Radiology Research Governance Committee
was established under the Chairmanship of Dr Christopher
Boyd. The committee meets monthly to oversee all research
within the directorate and has developed close links with the
NICCTU to help facilitate all cancer trials within the Trust. The
Radiology Research Governance Committee has been involved
in excess of 100 trials since 2004. The scope and complexity
of work varies between trials but typically involves patient
care pathways, trial protocol review, image quality, costings
and radiation protection issues. The committee liaises closely
with NICCTU and the radiation protection advisor of the N.
Ireland Regional Medical Physics Agency on relevant aspects of
each trial. The range of currently active trials refects the wide
spectrum of malignancies seen in the population served by the
Belfast Health & Social Care Trust.
The Radiology Research Governance Committee seeks to
develop and enhance a culture of active research within the
Radiology Directorate. A dedicated research account has been
established to help researchers with fnancial aspects of their
work as well as assist attendance at national and international
meetings. New imaging technology such as CT-PET is currently
being incorporated in both national and local investigator-led
Clinical Laboratories
We integrate clinical research work within the NHS labs in
Haematology, Clinical Chemistry, Cytology, Tissue Pathology
and any other discipline as appropriate. Professor Dennis
Alexander leads on Research Governance for the clinical
laboratories. There is much use of laboratory resources to
facilitate clinical trials, but there are also many research
projects developed and led by staff from the labs. There is
liaison on laboratory studies with the basic and translational
science programmes of both QUB and the University of Ulster.
Hospital Services
n i c c t u
n i c c t u
Research Areas
NorIherh Irelahd Cahcer
Clihical 1rials UhiI
As a dedicated Experimental Cancer Medicine Centre (ECMC),
the NICCTU aims are:
to drive the development of Phase I and II trials,
to facilitate the translation of pre-clinical ideas into the
clinical arena and back again
to facilitate the translation of pre-clinical ideas into the
clinical arena and back again so that fndings in patients
inform our basic science research.
Our intention is to:
increase the number of laboratory studies as part of
mechanistic Phase I and early Phase II clinical trials
enhance predictive marker development as part of clinical
therapeutic studies
increase the number of patients entered into Phase I and II
clinical trials
increase the overall number of Phase I, Phase II and
translational studies.
Novel agents have been obtained from Cancer Research UK
Phase I/II and New Agents Committees and the pharmaceutical
industry. Local investigator-initiated studies are also performed
and encouraged. Several translational clinical trials have been
opened and others, informed by our translational science
programme, are scheduled to open soon. Translational
imaging studies that incorporate in vivo pharmacodynamic
endpoints are also planned using our state of the art combined
CT/PET scanner. Pharmacokinetic, pharmacodynamic and
pharmacogenetic assays are all involved and may use both
tumour and normal tissues.
Early clinical trials (ECTs) may be open to any patient with
an incurable malignancy that no longer is responsive to
standard therapies, or in whom there is no such standard care
treatment. Increasingly nowadays, these trials may only be
open to patients with certain tumours defned by site of origin
or a particular genetic or behavioural profle. Hence, early
clinical trials are increasingly offered in frst-, second- or third-
line treatment settings. We aim to have a mixed portfolio of
ECTs covering several of these different areas at any one time.
We collaborate with the other members of the ECMC
Network, Cancer Research UK, Pharmaceutical and biotech
companies for these trials.
n i c c t u
Dr Richard Wilson Professor
Patrick Johnston
Mr Conal Askin
Tissue Procurement Technician
Dr Richard Wilson
(Clinical) and
Professor Patrick
Dr Martin Eatock
Early Clinical Trials and
Translational Research
There has been a signifcant impact on the routine
management of upper GI cancers (oesophago-gastric,
pancreatic, liver, biliary tract and small bowel malignancies,
neuro-endocrine tumours and GI stromal tumours) as a
result of clinical trials which we have participated in over
the last 5 years. These trials have clarifed the role of neo-
adjuvant therapies for resectable oesophago-gastric cancer,
have established the role of chemotherapy combinations
in advanced pancreatic cancer and have established the
role of chemotherapy in the adjuvant treatment of resected
pancreatic cancer. Despite this, the outlook for patients
with upper GI tract malignancy remains poor and there is a
desperate need for improved understanding of the biology of
this group of malignancies and to develop new treatments for
these patients.
There has been a signifcant emphasis on translational research
in relation to proposed clinical trials in upper GI malignancy
which will result in a greater understanding of the biology
of these malignancies, and may also be of use in making
decisions about appropriate use of existing treatments.
Current and future trials will fall into three groups:
Trials of new agents in the management of advanced disease
Studies of novel imaging techniques in the early assessment
of response to treatment
Improving treatment outcomes in patients with resectable or
resected upper GI malignancies
The Upper GI trials team has ongoing collaborations with
ICORG, the Beatson Oncology Centre (Glasgow), the Christie
Hospital (Manchester) and Mount Vernon Hospital (London).
Dr Eatock has conducted a number of single centre phase I
investigator-initiated trials including ELTAX and VECARBOX
and has recently designed the ELECT multi-centre, randomised,
phase II study that opened in summer 2007.
Dr Martin Eatock
n i c c t u
Upper Gastrointestinal Cancer
Dr Martin Eatock
Dr David Conkey,
Dr Robert Harte,
Dr Claire Harrison,
Dr Paul Henry,
Dr Russell Houston,
Dr Richard Park,
Dr Sandra Van
There is an active portfolio of trials in lower GI cancer. Dr
Wilson has incorporated novel agents in phase I, II and III
trials in treatment of frst-, second- and third-line metastatic
colorectal cancer (CRC) such as Zactima (an orally active
inhibitor of EGF and VEGF2 receptors), AZD2171 (an oral
receptor tyrosine kinase inhibitor of VEGF receptors) and
VEGFTrap. There are also a series of large, international multi-
centre trials in CRC such as the QUASAR2 trial in adjuvant
therapy and the COIN trial in the frst-line metastatic setting.
Dr Wilson is a member of the Trial Management Group of
both these trials, and helped to develop them. Dr Wilson
also led a randomised, prospective, multi-centre, double-
blind, placebo-controlled study of transdermal AGI004 for
the control of chemotherapy-induced diarrhoea. If there is
evidence of beneft of this agent, the company has agreed that
Dr Wilson will bring a future phase III RCT of this agent to the
NCRI Colorectal Clinical Study Group.
Dr Harte leads in lower GI radiotherapy and has strongly
promoted the ACTII trial in anal cancer which recruited very
well. The NSCCG is a large genetic epidemiology study which
is recruiting actively for both patients and controls.
Translational work is being carried out in Belfast under the
leadership of Prof Johnston. This includes translational aspects
of large phase III trials such as COIN, e.g. the use of gene
expression profling as a molecular predictor of response. We
are also assessing circulating tumour cells in CRC as a source
of material for gene expression profling and translational
studies as an alternative to material sourced from invasive
biopsies. Prof Johnston continues to lead the work in NICCTU
and CCRCB in biomarker discovery and predictive testing in
Further clinical trials are in development in CRC through the
NCRI Colorectal Clinical Study Group and translational trials
with US co-operative groups.
n i c c t u
Dr Richard Wilson Professor
Patrick Johnston
Dr Richard Wilson
(Clinical) and
Patrick Johnston
Dr David Conkey,
Dr Martin Eatock,
Dr Claire Harrison,
Dr Robert Harte,
Dr Paul Henry,
Dr Russell Houston,
Dr Richard Park,
Dr Sandra Van
Lower Gastrointestinal Cancer
Urological cancers represent a very signifcant proportion of
the workload of the Cancer Centre. Prostate cancer is now
the most commonly diagnosed cancer and the second most
common cause of cancer death in men with almost 10,000
deaths annually in the UK. Bladder and Renal Cell cancer are
responsible for 5,000 and 3,500 deaths respectively every
year in the UK. Our major clinical trial interest in urological
cancer in Belfast centres on prostate cancer however we
also participate in studies in bladder cancer, renal cell cancer,
and testicular cancer. Dr. OSullivan is a member of the NCRI
Prostate Clinical Study Group.
The Urological Oncology team is a group made up of
dedicated multi-professionals including Urological Oncology
surgeons, oncologists, specialist nurses, research nurses and
research radiographers. Our clinical practice is centred on the
multi-disciplinary team meeting which takes place on a weekly
basis and is attended by the research team.
A major ambition of our Urological Cancer research
programme is to develop translational research with our
scientifc colleagues. We are recruiting to a biomarker study
in metastatic prostate cancer patients being treated with
Dexamethasone, examining the relationship between PSA
response and changes in Interleukin-8 levels in serum. This
study was developed between ourselves and Dr. David
Waughs Group at the Centre for Cancer Research and
Cell Biology at Queens University. We are about to open a
translational study in superfcial bladder cancer in conjunction
with Dr. Kate Williamsons group at Queens.
We actively participate in a number of multi-centre urological
cancer clinical trials including
STAMPEDE (Prostate)
BC1-06 (Radium-223, Prostate)
Abiraterone (Prostate)
There is some overlap with the radiation oncology research
programme including
Spinal Cord Compression Study
CHHIP (Prostate)
BUS (Bladder)
Dr Alison Clayton Dr Seamus
Dr Joe OSullivan
n i c c t u
Urological Oncology
Dr Alison Clayton
(Renal Cancers),
Dr Seamus McAleer
(Germ Cell Tumours)
Dr Joe OSullivan
(Prostate and
Bladder Cancers)
Dr Ruth Eakin,
Dr Jackie Harney,
Dr Jonathan
Dr Darren Mitchell,
Dr Lin Shum,
Dr David Stewart,
Dr Stephen Stranex.
Dr OSullivan is the Chief Investigator of an investigator initiated
phase I study combining repeated administration of the bone-
seeking radionuclide, Rhenium -186 HEDP with Taxotere in the
treatment of metastatic hormone refractory prostate cancer.
This study is being conducted in collaboration with colleagues
in Amersfoort (Holland) and has been funded by industry.
Dr Alison Clayton leads the Renal Cell Carcinoma team.
We have just opened
SORCE a randomised trial to determine whether adjuvant
sorafenib will reduce the risk of disease relapse for patients
following surgery for renal cell cancer.
Our future strategy for Urological cancer clinical trials in Belfast
is to build on our NCRN trials portfolio and to further develop
our investigator initiated programme, in particular in the
feld of radionuclide therapy combined with chemotherapy.
We also plan to expand our translational research portfolio
and increase our participation in pharmaceutical industry
sponsored clinical research.
Dr Seamus McAleer leads our clinical trials in testicular and
other germ cell tumours. Several studies in teratoma and
seminoma of various stages have been conducted over the
years and several other clinical trials in testicular cancer are
currently under consideration and likely to be adopted in the
next few months.
Urological Oncology
n i c c t u
There are over 400 new cases of gynaecological cancers
diagnosed annually in Northern Ireland. Patients are discussed
at the weekly multi-disciplinary meeting which is supported
by involvement from pathology, radiology and palliative care.
All patients with a diagnosis of a gynaecological malignancy
are discussed at the meeting and most have their surgical
treatment here in the BCH.
The Gynaecology Oncology research team includes fve
oncologists, fve gynaecology surgeons and a research nurse.
The team has an excellent track record of recruitment into
both investigator led and industry sponsored trials. The
team has a long history of collaboration with the Scottish
Gynaecology Cancer Clinical Trials group and has made
signifcant contributions to SCOTROC 1, SCOTROC 2 and
SCOTROC 3 examining innovative treatments in ovarian
cancer. We have also recruited to MRC trials including ASTEC
and EORTC trials including EORTC 55984 looking at treatment
options in endometrial cancer.
In terms of screening trials signifcant contributions have been
made to the UKTOCS and UKFOCS trials examining the value
of ultrasound and CA 125 in the early detection of ovarian
cancer both in a general population and in those patients
deemed to be at high risk.
A number of trials in both ovarian and endometrial cancer are
open and actively recruiting and include for example UKOPS,
The future aim of the team is to continue to expand the range
of trials open to patients and to improve recruitment.
Dr Jackie Clarke Dr Colin James
n i c c t u
Dr Jackie Clarke
Dr Stephen Dobbs
Dr Sarah McKenna
Dr Colin James
Dr Anne Drake,
Dr Joanne Millar
Gynaecological Cancer
Dr Sarah McKenna
Breast cancer is the most common malignancy affecting
women in the Western World. There are over 41,000 new
cases each year in the UK alone, with an annual mortality
of approximately 13,000. One woman in 9 is affected at
some time in her life. More effective treatments are urgently
Breast cancer mortality rates are falling, and this is likely due
to a combination of earlier detection and treatment, and
development of more effective treatments. In the adjuvant
setting following surgery, effective therapy may eradicate
residual disease leading to long term cure; and for women
with advanced, incurable disease, newer therapies are leading
to signifcant improvements in duration of survival.
A major challenge being addressed at present relates to our
increased understanding of the biology of breast cancer which
is no longer considered a single disease. It is now recognised
that the genetic make-up of different types of breast cancer
may determine which therapies will and which will not be
effective hopefully leading to a more individualised approach
to therapy in the future.
The clinical breast cancer team in Northern Ireland includes
six clinical and four medical oncologists providing services
in Belfast and also in the cancer units at the Ulster Hospital,
Craigavon Area Hospital, Antrim Area Hospital and Altnagelvin
Hospital. The opening of the Northern Ireland Cancer Centre
in March 2006 has enabled greater collaboration between
clinical and medical oncology and will facilitate future
translational research.
The breast oncology group aims to increase participation in
clinical trials as this is seen as the best way to optimise patient
care. Examples of some recent and ongoing trials include:
The AZURE trial examining whether adjuvant zoledronate
therapy improves disease free survival in women with early
breast cancer in addition to standard therapy.
The PRIME II trial investigating the role of radiotherapy
following surgery for elderly women with low risk disease.
Dietcomplyf is an observational study looking at the potential
effect of lifestyle and dietary factors on breast cancer
TACT 2 is a trial comparing different chemotherapy regimens
for early breast cancer looking both at intensifying therapy
and also at the role of oral chemotherapy with capecitabine
in the adjuvant setting.
Dr Jackie Clarke Dr Alison Clayton
Dr Colin James
Dr Jackie Clarke
Dr Alison Clayton
(Systemic Therapies),
Dr Colin James
Dr Paul Abram,
Dr Paul Henry,
Dr Seamus McAleer,
Dr Sarah McKenna,
Dr Angus Patterson,
Dr Paula Scullin
Breast Cancer
n i c c t u
Trials which will open in Belfast over the next year include
Dr James is leading the collaboration on translational work on
breast cancer with Prof Harkins and other laboratory groups
in CCRCB. Our interest in DNA repair defciency will lead to
feasibility trials of new agents targeting this in the future in
breast cancer.
Breast Cancer
n i c c t u
Our paediatric oncologists have run phase II and III trials in
children with haematological and solid malignancies in the
Royal Belfast Hospital for Sick Children for many years. Belfast
is part of the UK Childens Cancer and Leukaemia Group
(CCLG) who develop and co-ordinate their trials. Studies are
open in germ cell tumours, acute myeloid and lymphoblastic
leukaemia, Wilms tumour, Ewings sarcoma, and Non-Hodgkins
Lymphoma. Dr Jackie Harney and Dr David Conkey run the
radiotherapy component of paediatric trials. Our paediatric
trials are supported by our paediatric CRNs Ms Valerie Wallace
and Ms Sinead Gallagher.
Dr Anthony
Paediatric Oncology
Dr Christine
(Haematology) and
Dr Anthony
McCarthy (Solid
Lung Cancer and Mesothelioma
Dr Dean Fennell
Dr Jonathan
McAleese (Clinical)
Dr Dean Fennell
Dr Ruth Eakin,
Dr Jackie Harney,
Mr Kieran McManus,
Dr David Stewart,
Dr Stephen Stranex,
Dr Paula Scullin
The NICCTU has a developing portfolio of lung cancer and
mesothelioma clinical trials. The lung cancer team includes
professionals from a variety of backgrounds including medical
and clinical oncologists, thoracic surgeons, specialist and
research nurses, trial co-ordinators and data managers.
The team continues to develop its involvement in lung cancer
through its association with National Cancer Research Network
(NCRN), Irish Cooperative Oncology Research Group (ICORG),
British Thoracic Oncology Group (BTOG) and European
Organisation for Research and Treatment of Cancer (EORTC)
groups. Dr Dean Fennell is the clinical lead for systemic
treatment trials with Dr David Stewart and Dr Jonathan
McAleese developing radiotherapy trials and Mr Kieran
McManus leading on surgical aspects.
Recent trial work has included two studies in advanced
NSCLC: one investigating the antiangiogenic monoclonal
antibody bevacizumab with chemotherapy, the other
examining the role of a toll-9 agonist with Gembitabine and
Cisplatin chemotherapy. Dr Dean Fennell has developed a
multicentre phase II trial of Velcade, a proteosome inhibitor, in
mesothelioma, and several more studies with small molecule
inhibitors targeting apoptosis are in development.
Northern Ireland is very fortunate in having CT-PET scanning
available for lung cancer patients and consequently CT-PET
scanning is another avenue of research and development: a
pilot study of the feasibility of CT-PET in radiotherapy planning
is currently underway and further studies are planned in
evaluation of response to treatment in NSCLC and staging in
SCLC. In addition many of the lung cancer and mesothelioma
trials incorporate associated translational protocols to explore
the correlation between molecular pathology and clinical
outcome and develop new therapeutic strategies.
n i c c t u
Haematological Malignancy
Professor Mary
Frances McMullin
Professor Curly
Professor Mary
Frances McMullin
(Leukaemia and
Disorders) and
Professor Curly
Morris (Lymphoma
and Myeloma) and
Professor Ken Mills
Dr Robert Cuthbert,
Dr Mary Drake,
Dr Frank Jones,
Dr Paul Kettle,
Dr Michael Quinn
Lymphoma and Multiple Myeloma
Multiple myeloma remains a fatal and debilitating illness but
the outlook for patients with this disorder is changing. In
the previous decade development of equipment and drugs
to assist with mobilising stem cells has brought autologous
transplantation into the realm of routine treatment for
patients aged up to 70 years (who are otherwise medically
ft), and these patients have an extended median survival
from 3 years to 5 years. The current decade is witness to
even more exciting developments with the introduction of
a number of new agents for the treatment of myeloma all
of which work in a novel fashion. The frst of these drugs is
thalidomide which is known to produce responses in 30-40%
of refractory patients. This response rate can be doubled
by the addition of dexamethasone. Thalidomide interferes
with cell-cell interactions and chemical messengers which
stimulate the myeloma cell and down regulates cytokines
driving myeloma cell division. Development of the novel
proteasome inhibitor bortezomib, an entirely new class of anti-
tumour drug has seen signifcant improvements in outcomes.
Recently thalidomide analogs such as lenalidomide have also
shown effcacy in phase III trials and will be shortly licensed.
Although these drugs have similar effects to thalidomide
they are independent and not cross resistant. BCH has taken
part in clinical trials in all these agents and was involved in
the licensing trials of both bortezomib and lenalidomide.
In conjunction with Dr Sandra Irvine there is also an active
proteasome inhibitor research group studying patients
with myeloma. Future development will take a number
of directions. Combinations of bortezomib with existing
cytotoxics were predicted by in vitro studies to be effective.
Phase II studies carried out in our unit have confrmed
these hopes. Investigators in the unit are now working on
an international Phase III study using the combination of
bortezomib, adriamycin and dexamethasone for relapsed
patients on the basis of the Phase II work.
Leukaemia and Myeloproliferative Disorders
A large Phase III trial (MRC AML 15) is open where all patients
under the age of 60 are entered into the trial should they so
wish. This trial compares standard therapy and combinations
with the leukaemia cell targeted therapy Myelotarg. So far
results are better than any previous AML trial with over 90%
of patients going into remission. In the over 60 age group,
the LRF AML 14 trial is now complete and AML 16 which will
look at a number of different experimental therapies as well
as standard treatment in this older group has just opened.
n i c c t u
Professor Ken Mills
AML 17 which will replace AML 15 is due to open soon. Our
group has also participated in several Phase II trials looking
at newer agents in acute myeloid leukaemia, particularly in
the elderly age group. The agent Clofarabine has produced
some impressive remissions in the group of patients as seen
during the Phase II trial. In the unfortunate group of patients
with Philadelphia positive disease this trial will continue for
a little longer. In chronic myeloid leukaemia the SPIRIT trial is
open to recruitment and looks at higher doses of Imatinib and
adding Interferon to the standard treatment of chronic myeloid
leukaemia. The low risk and intermediate risk arms of the MRC
primary thrombocythaemia trial remains open and continues
to recruit steadily from this centre. We have also been looking
at other areas in the myeloproliferative diseases. This centre
has undertaken a Phase I/II trial of the pharmacokinetics of
Anagrelide through the regulatory authorities in the UK. This
is an important trial as this drug has been available for some
time but the pharmacokinetics in the older age group are
unclear. Many elderly use this drug and this trial will study this
further. We also have a registration study which is suitable
for most of our essential thrombocythaemia patients. We
participate in a worldwide registry of paroxysmal noctural
haemoglobinuria. This study is attempting, in this rare disease,
to enrol 1,000 patients worldwide and follow them up for at
least fve years so that we may obtain a better picture of the
ongoing morbidity and mortality in this rare disorder.
Our leukaemia and myeloproliferative patients also participate
in trials involving translational research. In acute myeloid
leukaemia bone marrow cells are collected at diagnosis for
studies into HOX genes in collaboration with Professor Terry
Lappin and proteins involved in cell death in collaboration
with Professor Patrick Johnston. In chronic myeloid leukaemia,
bone marrow samples are collected at diagnosis and follow-up
for studies in the proteosome in chronic myeloid leukaemia
in collaboration with Dr Sandra Irvine. All of these studies
are directed at looking at the mechanisms of disease on
possible future therapeutic strategies. The research group of
Professor Ken Mills is focused on myelodysplastic syndrome
and acute myeloid leukaemia with the aim of defning the
disease process involved in the progression between these
disease entities. Professor Mills participates in international
and multicentre studies using gene expression profling for
disease classifcation and diagnosis which have resulted in the
identifcation of gene pathways and functions that could lead
to therapeutic targets. His collaboration with the NCRI AML15
and 16 trials involves the analysis of epigenetic status at
diagnosis as a potential for identifying therapeutic responses.
Haematological Malignancy
n i c c t u
Radiation oncology research is a major element of our cancer
clinical trials programme. Radiation therapy is one of the key
modalities in the treatment of cancer and has a signifcant role
in the cure and palliation of many tumours. There have been
many technological developments in the feld of radiotherapy
over the past 10 years including Three-Dimensional Conformal
Radiotherapy, Intensity Modulated Radiation Therapy (IMRT)
and Image-Guided Radiation Therapy (IGRT). The principle of
our radiation oncology research strategy in Belfast is that of
multi-disciplinary and cross-faculty team working held together
by the cornerstone of academic Clinical Radiation Oncology.
At present there is one clinical academic radiation oncologist
(Dr Joe OSullivan). Dr OSullivan is a member of the NCRI
Radiotherapy Clinical Study Group.
The Radiation Oncology Research team is made up of a
dedicated group of multi-professionals including clinicians,
physicists and research radiographers. We have a large
radiotherapy department with 8 clinical Linear Accelerators,
CT simulator, and a state of the art radiology department
dedicated to oncology. Funding has recently been approved
by a local cancer charity (Friends of the Cancer Centre) in
conjunction with Queens University to provide a dedicated
research linear accelerator for use in the Cancer Centre.
We are currently recruiting well to a number of national and
international external beam radiation therapy clinical trials
including ACT II, PRIME II, QUARTZ and CHHIP. We were one
of the biggest recruiters to the START trial as well as the PRO7
study. We also have an interest in radionuclide therapy and
are currently recruiting to an international randomised trial of
Radium-223 in metastatic prostate cancer.
We have an active investigator-initiated radiation research
programme. Dr Alan Hounsell (Medical Physics) leads a study
examining the role of PET/CT in radiotherapy treatment
planning for Non-Small Cell Lung Cancer. This research
programme, funded by a grant from the R&D Offce has
been running for the past 2 years and is now moving onto
the next phase of development. Funding has been approved
for a Clinical Research Fellowship to work in this feld and
further develop the clinical research programme. We have
developed, in conjunction with colleagues in ICORG, a Phase III
randomised clinical trial of two radiation fractionation schemes
in the treatment of malignant spinal cord compression.
Dr Joe OSullivan
Dr Joe OSullivan
Radiation Oncology Research
Dr OSullivan is also leading a study combining repeated
administration of the bone seeking radionuclide, Rhenium-186
HEDP with Taxotere in metastatic hormone refractory prostate
Another very important strand of our clinical trials programme
in radiation oncology is collaboration with our radiation
science colleagues. Queens University have recently appointed
Professor Kevin Prise, Chair of Radiation Science, who has
greatly enhanced our ability to translate laboratory discovery
into patient beneft. We also have collaboration with Professor
David Hirst (School of Pharmacy) on development of the use
of gold nanoparticles.
Our strategy for the next 5 years is to increase our portfolio
of NCRN radiotherapy clinical trials, to further develop our
Image-Guided Radiotherapy and bone-seeking radionuclide
programmes and to expand our translational research
programme. We are also keen to increase our collaboration
with industry.
Research Radiography and Medical Physics
(left to right) Dr Suneil Jain, Mrs Angela ONeill,
Dr Gerry Hanna, Mr Conor McGarry, Dr Joe
OSullivan, Mrs Sharon Hynds, Dr Alan Hounsell
Radiation Oncology Research
n i c c t u
n i c c t u
The Northern Ireland Cancer Centre manages more than 100
melanoma patients per year and patients presenting with
high risk primary tumours have been offered participation
in the Cancer Research UK study which compares high dose
interferon given for either one month or one year. Other
adjuvant therapies using small molecules are being considered
with the hope of having clinical trials available for patients
with advanced melanoma. Currently patients with advanced
malignant melanoma are being referred to the Early Clinical
Trials team where a number of patients have been entered
into phase I and phase II trials of novel therapies such as one
involving Temozolomide and a PARP inhibitor.
Palliative and Supportive Care
Supportive and palliative care have been poorly supported
areas for research in the UK and globally, even in the era of
NCRI and NCRN. In view of this, and the clear patient need in
these areas, NICCTU wishes to prioritise research in this feld.
Dr Max Watson has pioneered clinical trials locally in palliative
and supportive care and is a member of the NCRI Palliative
and Supportive Care CSG. He has run a series of clinical
research studies in the problems of cancer-associated anorexia,
cachexia and fatigue. In Spring 2009, we will commence a
single arm phase II feasibility trial of an immunomodulant,
IAD, in cancer cachexia. This study will include translational
work using a 50 molecule cytokine/cytokine receptor array
aiming to defne a signature of response. If IAD appears
to have effcacy in this 50 patient trial, we plan a future
phase III RCT versus placebo in this setting. This study will
also lead to a potential future trial to validate the cytokine
array as a predictive tool for use in cancer cachexia, anorexia
and fatigue. There are also studies about to open in pain
evaluation, assessment of physical activity levels and
prognostic scoring in palliative medicine. NICCTU will work
closely with NI Hospice and Marie Curie Hospice to expand
clinical research in palliative and supportive care. A CRN will
be appointed to promote this research in the frst quarter of
Oncology surgery has also been a challenging area for
research in the UK over recent years. This is an important area
for development and growth for NICCTU. We will work with
oncology surgeons locally using the activities in surgical cancer
research led by Dr Dobbs and Mr McManus as a template, and
support the cancer surgeons working in the four cancer units
using our NICTN clinical research nurses.
Dr Seamus McAleer Dr Max Watson
Dr Seamus McAleer
(Melanoma) and
Dr Max Watson
(Palliative and
Supportive Care)
Dr Bernie Corcoran,
Dr Stephen Dobbs,
Mr Kieran McManus,
Dr Joan Regan,
Dr Pauline Wilkinson
Miscellaneous (including Melanoma,
Surgery, Palliative and Supportive care)
Trials Portfolio
NorIherh Irelahd Cahcer
Clihical 1rials UhiI
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
Mantle Cell Phase II Randomised Study Of Fludarabine /
Cyclophosphamide Combination With Or Without
Rituximab In Patients With Untreated Mantle Cell
III Cancer
Research UK
PAD A Phase II Study To Assess The Safety, Effcacy And
Tolerability Of Combination Therapy With Velcade,
Adriamycin And Dexamethasone (PAD) As Primary
Therapy For Patients With Myeloma
II Millennium
Stanford V A Randomised Phase III Study Of The Stanford V Regimen
Compared With ABVD For The Treatment Of Advanced
Hodgkins Disease
PET A Randomised Phase III Trial To Determine The Role
Of FDG-PET Imaging In Clinical Stages Ia/IIa Hodgkins
UKALL 12 Acute Lymphoblastic Leukaemia UKALL Trial XII.
A Protocol For Adult Patients With All Under 56 Years
Of Age
AML 15 Acute Myeloid Leukaemia Trial 15 in Adults and Children III MRC and
Cardiff Univ
PT1 An MRC Randomised Trial To Compare Aspirin Versus
Hydroxyurea / Aspirin In Intermediate Risk Primary
Thrombocythaemia And Hydroxyurea / Aspirin
Versus Anagrelide / Aspirin In High Risk Primary
III MRC funded
University of
Merit A Randomised, Controlled Trial Of Adjunctive Plasma
Exchange In Patients With Newly Diagnosed Multiple
Myeloma And Acute Renal Failure
III Imperial
College London
Watch & Wait An Intergroup Randomised Trial Of Rituximab Versus
A Watch And Wait Strategy In Patients With Advanced
Stage, Asymptomatic, Non-Bulky Follicular Lymphoma
(Grades 1, 2, 3a)
Genetic Study
Genetic Study Of Chronic Lymphocytic Leukaemia Gen Epi ICR
SPIRIT A Phase III Prospective Randomised Comparison of
Imatinib 400mg Versus Imatinib 800mg Versus Imatinib
Plus Pegylated Interferon In Patients With Newly-
Diagnosed Chronic Myeloid Leukaemia
III University of
AML 16 A Programme of Treatment Development for Older
Patients with AML or High Risk MDS
SPD A Non-Interventional Post Authorisation Safety Study to
Continuously Monitor Safety and Pregnancy Outcomes
in a Cohort of At Risk Essential Thrombocythaemia
(ET) Subjects Exposed to Xagrid

Compared to Other
Conventional Cytoproductive Treatments
Obs Shire
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
MDS A Randomised Controlled Trial Of Prolonged Treatment
With Darbepoetin Alpha And Recombinant Human
Granulocyte Colony Simulating Factor (G-CSF) Versus
Best Supportive Care In Patients With Low-Risk
Myelodysplastic Syndromes
London NHS
UKALL 2003 United Kingdom Childhood Acute Lymphoblastic
Leukaemia Randomised Trial 2003
PNH Paroxysmal Nocturnal Haemoglobinuria Patient Registry Obs Alexion Phar-
UKGPC UK Genetics Prostate Cancer Study Gen epi ICR
Stampede Systemic Therapy In Advancing Or Metastatic Prostate
Cancer Evaluation Of Drug Effcacy
III Cancer
Research UK
SORCE A Phase III Randomised Double Blind Study Comparing
Sorafenib With Placebo In Patients With Resected
Primary Renal Cell Carcinoma At High or Intermediate
Risk of Relapse
Abiraterone A Phase III Randomised Double Blind Placebo Controlled
Study Of Abiraterone Acetate (B7630) Plus Prednisone
In Patients With Metastatic Castration Resistant Prostate
Cancer Who Have Failed Docetaxel Based Chemotherapy
III Cougar
DEX-IL8 A Study Examining The Association Of Serum
Interleukin-8(L-8) With Response To Dexamethasone In
Metastatic Hormone Refractory Prostate Cancer (HRPC)
III Belfast HSC
ESPAC 3 Adjuvant Chemotherapies In Resectable Pancreatic
III Cancer
Research UK
/ University of
NSCCG National Study Of Colorectal Cancer Genetics Gen Epi ICR / Cancer
Research UK /
SOCS Stomach and Oesophageal Cancer Study Gen Epi Cancer
Research UK
/ Cambridge
AMG 386 A Randomised, Double-Blind, Multicentre, Phase II
Study To Estimate The Effcacy And Evaluate The Safety
And Tolerability Of Cisplatin And Capecitabine In
Combination With AMG 386 Or Placebo In Subjects
With Metastatic Gastric, Gastroesophageal Or Distal
Esophageal Adenocarcinoma
II Amgen
COIN A Phase III Trial Comparing Either Continuous
Chemotherapy Plus Cetuximab or Intermittent
Chemotherapy With Standard Continuous Palliative
Combination Chemotherapy With Oxaliplatin and a
Fluoropyrimidine in First Line Treatment of Metastatic
Colorectal Cancer
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
HORIZON II A Randomised, Double-blind, Phase III Study to Compare
the Effcacy and Safety of AZD2171 when added to
5-fuorouracil, Leucovorin and Oxaliplatin (FOLFOX) or
Capecitabine and Oxaliplatin (XELOX) with the Effcacy
and Safety of Placebo when added to FOLFOX or
XELOX in Patients with Previously Untreated Metastatic
Colorectal Cancer
III AstraZeneca
ASPECT Aspirin Esomeprazole Chemo Prevention Trial. A Phase
IIIb Randomised Study Of Aspirin And Esomeprazole
Chemo Preventation in Barretts Metplasia
IIIb University of
ABC02 Gemcitabine, Alone Or In Combination With
Cisplatin, In Patients With Advanced Or Metastatic
Cholangiocarcinomas And Other Biliary Tract Tumours:
A Multicentre, Randomised Phase III Trial.
Research UK &
Quasar II Multicentre International Study Of Capecitabine
Bevacizumab In Adjuvant Treatment Of Colon Cancer
III University of
A Phase II, Double-Blind, Placebo Controlled, Randomised
Study To Assess The Effcacy And Safety Of Two Doses
Of Zactima (ZD6474) In Combination With FOLFORI Vs
FOLFORI Alone For The Treatment Of Colorectal Cancer
In Patients Who Have Failed Therapy With An Oxaliplatin
And Fluoropyrimidine Containing Regimen.
II AstraZeneca
CRCCTU Isolation Of Circulating Colorectal Cancer Tumour Cells;
A Pilot Study
Trans Belfast HSC

17-DMAG A Cancer Research Uk Phase I Trial To Evaluate The
Safety, Tolerability And Pharmacokinetics Of 17-
(17-Dmag) Given As A Once Weekly Infusion In Patients
With Advanced Solid Tumours
I Cancer
Research UK
BIB A Multicentre 3-Arm Randomized Phase II Trial Of BIBF
1120 Verses BIBW 2992 Verses Sequential Administration
Of BIB1120 And BIBW 2992 In Patients With Hormone-
Resistant Prostate Cancer
II Boehringer
Nanocarrier Phase I Study To Determine The Maximum Tolerated Dose
of NC-6004 In Patients With Solid Tumours
I NanoCarrier
Co Ltd
VeCarboX A Dose Finding Study of Bortezomib in Addition to
Epirubicin, Carboplatin and Capecitabine (ECarboX) in
Advanced Gastric and Gastro-Oesophageal Junction
I Belfast HSC
ABT 751 Abbott Study M05-782 - A Phase 2 Study Evaluating
the Safety & Effcacy of ABT-751 in Combination with
Docetaxel Versus Docetaxel Alone in Subjects with
Advanced or Metastatic Non-Small Cell Lung Cancer
II Abbott
Rhenium &
A Phase I study of combined docetaxel and repeated
Rhenium-186 HEDP in hormone refractory prostate cancer
metastatic to bone
I Belfast HSC
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
Fuzzy Logic Use Of Fuzzy Logic Based Analysis Of Tumour Markers As
A Diagnostic Tool For Lung Cancer
Trans Christie &
Velcade Meso An International Multicentre Phase II Clinical Trial Of
Velcade As First Or Second Line Therapy Of Malignant
Pleural Mesothelioma
EORTC 08062 Randomised Phase II Study Of Amrubicin As Single Agent
Or In Combination With Cisplatin Versus Etoposide-
Cisplatin As First-line Treatment In Patients With Extensive
Stage SCLC(ES)
Mage A3 A Double Blind Randomised Placebo Controlled Phase III
Study To Assess Effcacy Of recMAG-A3 + AS15 Antigen
Specifc Cancer Immunotherapeutic As Adjuvant Therapy
In Patients With Resectable MAGE A3 positive Non-
Small Cell Lung Cancer
III GlaxoSmith-
Chorus Chemotherapy Or Upfront Surgery. A Randomised
Feasibility Trial To Determine The Impact Of Timing Of
Surgery And Chemotherapy In Newly Diagnosed Patients
With Advanced Epithelial Ovarian, Primary Peritoneal Or
Fallopian Tube Cancer
Scotroc IV Randomised Trial Of Adriamycin (A) Cisplatin (P)
Chemotherapy Versus Paclitaxel (T) Adriamycin (A) And
Cisplatin (P) In Patients With Metastatic / Relapsed Or
Locally Advanced Inoperable Endometrial Cancer
III Glasgow
UK OPs Risk Prediction And Early Detection Of Ovarian Cancer Screening University
College of
EPO906 A randomised, parallel group, open label, active
controlled, multi-centre phase 3 trial of patupilone
(EPO906) versus pegylated liposomal doxorubicin (Doxil/
Caelyx) in taxane / platinum refractory / resistant patients
with recurrent epithelial ovarian, primary fallopian or
primary peritoneal cancer.
III Novartis
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
POSH Prospective Study Of Outcomes In Sporadic Versus
Hereditary Breast Cancer
Obs Southampton
Hospital Trust
IBIS II DCIS IBIS II Dcis An International Multi-Centre Study Of
Tamoxifen Vs Anastrozole In Postmenopausal Women
With Ductal Carcinoma In Situ (Dcis)
III Cancer
Research UK /
IBIS II Prevention An International Multi-Centre Study
Of Anastrozole Vs Placebo In Postmenopausal Women At
Increased Risk Of Breast Cancer
III Cancer
Research UK /
IBIS II Bone IBIS II Bone Sub - International Breast Cancer
Intervention Study (IBIS) Of Anastrozole Vs Placebo In
Postmenopausal Women At Increased Risk Of Breast
Cancer Bone Sub Study.
III Cancer
Research UK /
DietComply The Role Of Diet And Lifestyle In Survival After Breast
TACT II Trial of Accelerated Adjuvant Chemotherapy With
Capecitabine in Early Breast Cancer
III Cancer
Research UK
FACE A Randomised Multi-Centre Phase IIIb Open-Label Study
of Letrozole Vs Anastrozole In The Adjuvant Treatment of
Post-Menopausal Women With Hormone Receptor And
Node Positive Breast Cancer
III Novartis
OHERA An Observational of Cardiac Events In Patients With HER2
positive Early Breast Cancer Treated With Herceptin
Obs Roche
BRITS A Study To Assess The Change in Oestrogen Receptor
Status Between Original Diagnosis And The Subsequent
Recurrence Of Breast Cancer (Breast Recurrence in
Tissues Study)
Obs AstraZeneca
UK Ltd.
SOFEA A Partially Blind Phase III Randomised Trial of Fulvestrant
(Faslodex) With or Without Concomitant Anastrozole
(Armidex) Compared with Exemestane in Post
Menopausal Women With ER +ve Locally Advanced /
Metastatic Breast Cancer Following Progression On Non
Steroidal Aromatase Inhibitors
III Institute
of Cancer
Research and
Royal Marsden
LEAP An Open-Label Expanded Access Study Of Lapatinib
And Capecitabine Therapy In Subjects With ErbB2
Overexpressing Locally Advanced Or Metastatic Breast
IV Glaxo Smith
CRUK HDI Phase II Pilot Study Of Intravenous High Dose Interferon
With Or Without Maintenance Treatment In Melanoma
At High Risk Of Recurrence
II Cancer
Research UK
ActivPAL Physical Activity Level As An Outcome Measure In Cancer
Cachexia Trials
II University of
AGI Phase II A Randomised Prospective Multicentre Double Blind
Placebo Controlled Study Of Transdermal AGI 004 For
The Control of Chemotherapy Induced Diarrhoea
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
Spinal Cord
A Randomised Phase III Trial OF Two Fractionation
Schemes In The Treatment Of Malignant Spinal Cord
III Belfast HSC
Trust & SLH
BC 2001 Chemo-Radiotherapy And Whole Bladder Radiotherapy
With Tumour Boost In The Conservation Treatment Of
Muscle Invasive Bladder Cancer
III NCRI / Cancer
Research UK
BC 1-06 Double Blind Randomised Multiple Dose Phase III Multi
Centred Study Of Alpharadin In The Treatment Of
Patients With Symptomatic Hormone Refractory Prostate
Cancer With Skeletal Metastatis
III Pharmanet Ltd
& Algeta ASA
EORTC 22991 Three Dimensional Conformal Radiotherapy / Intensity
Modulated Radiotherapy Alone Vs Three Dimensional
Conformal Radiotherapy / Intensity Modulated
Radiotherapy Plus Adjuvant Hormonal Therapy In
Localised T1 B-C, T2a, N0, M0 Carcinoma
BUS An Observational Study Assessing Bladder Volume
Consistency During 3D Conformal Prostate Radiotherapy
Using An Ultrasonic Bladder Scan Device
Obs Belfast HSC
ACT II The Second UK Phase III Anal Cancer Trial: A Trial Of
Chemoradiation And Maintenance Therapy For Patients
With Anal Cancer
III Cancer
Research UK
PRIME II A Randomised Breast Cancer Trial To Assess Local Control
In Older Patients (Incorporating The PRIME Quality Of
Life Trial)
III Edinburgh
SUPREMO A Phase III Randomised Trial To Assess The Role Of
Adjuvant Chest Wall Irradiation In Intermediate Risk
Breast Cancer After Mastectomy
CHHIP Conventional Or Hypofractional High Dose Intensity
Moedulated Radiotherapy For Prostate Cancer
of Cancer
QUARTZ A Phase III Mult-Centre Randomised Controlled Trial
To Assess Whether Optimal Supportive Care Alone
(including Dexamethasone) Is As Effective As Optimal
Supportive Care (Including Dexamethasone) Plus Whole
Brain Radiotherapy In The Treatment Of Patients With
Inoperable Brian Metastases From Non-Small Cell Lung
ALL 2003 A United Kingdom Childhood Acute Lymphoblastic
Randomised Trial 2003
ALL R3 A Trial Looking At Treatment For Children and Young
People With Acute Lymphoblastic Leukaemia
III University
Hospitals of
AML 15 Acute Myeloid Leukaemia Trial 15 in Adults and Children III MRC
ET 2003 04 EURO Ewing 99 A Trial Looking At Treatment for
Children and Young People with Ewings Sarcoma and
Peripheral Primitive Neuroectodermal Tumour (pPNET)
EURO Ewing 99 Irinotecan Phase II II
Trials Portfolio
Open Trials
Acronym Full study title Phase Sponsor
CNS 2004 03 Low Grade Glioma A Trial Looking at Treatment for
Children and Young People With Low Grade Glioma
Brain Tumours
2001 06)
HART Hyperfractionated Accelerated Radiotherapy
(HART) With Chemotherapy (Cisplatin, CCNU, Vincristine)
For Metastatic M1-3 Medulloblastoma
CNS 1999 04 SIOP Ependymoma 99 III University
Hospitals of
Leicester NHS
LT 2004 09 SIOPEL 4 II/III University
Hospitals of
Leicester NHS
LT 2003 01 Hepatoblastoma Irinotecan Phase II II
GC 2005 04 Germ Cell Tumour University
Hospitals of
Leicester NHS
RB 2005 11 Management of children with Unilateral Retinoblastoma N/A University
Hospitals of
Leicester NHS
NB 2002 06 High Risk Neuroblastoma III University
Hospitals of
Leicester NHS
STS 2006 04 Non Metastatic Rhabdomyosarcoma III University
Hospitals of
Leicester NHS
NHL 2000 06 Anaplastic Large Cell Lymphoma III University
Hospitals of
Leicester NHS
WT 2001 02 SIOP Wilms Tumour III University
Hospitals of
Leicester NHS
WT 2002 02 UKWR Relapsed Wilms
Molecular Techniques in Paediatric Sepsis
Teicoplainin for the treatment of Coagulase Negative
Staph in CVCs
CNS 2001 04 Intavenous Etoposide in relapsed Ependymoma II University
Hospitals of
Leicester NHS
Trials Portfolio
Pending Trials
Acronym Full study title Phase Sponsor
TNT A Randomised Phase IIIComparative Trial Of Carboplatin
Versus Docetaxel For Patients With ER- PR- HER2-
Advanced Breast Cancer
III Guys & St
Thomas NHS
Trust / The
of Cancer
SOFT A Phase III Trial Evaluating The Role Of Ovarian Function
Suppression And The Role Of Exemestane As Adjuvant
Therapies For Premenopausal Women With Endocrine
Responsive Breast Cancer
III Breast
Cleopatra A Phase III, Randomised, Double-Blind, Placebo-
Controlled Clinical Trial To Evaluate The Effcacy And
Safety Of Pertuzimab + Trastuzumab + Docetaxel
Vs Placebo + Trastuzumab + Docetaxel In Previously
Untreated HER2 Positive Metastatic Breast Cancer
III Roche
BIG1-02 A Randomized Clinical Trial Of Adjuvant Chemotherapy
For Radically Resected Loco-Regional Relapse Of Breast
BEATRICE An International Multi-centre Open Label 2 Arm Phase III
Trial Of Adjuvant Bevacizumab In Triple Negative Breast
III Hoffmann-La
Roche Ltd
Persephone Duration Of Trastuzumab With Chemotherapy In Women
With Early Breast Cancer: Six Months Versus Twelve
III Cambridge
TAILOR X Trial Assigning Individualized Options For Treatment III ICORG
M10-265 A Phase II randomised, placebo-controlled double-blind
study of ABT-869 in combination with Paclitaxel versus
Paclitaxel alone as frst-line treatment in subjects with
locally recurrent or metastatic breast cancer.
II Abbott
TELOVAC A Prospective Phase III Controlled Multicentre
Randomised Clinical Trial Comparing Combination
Gemcitabine And Capecitabine Therapy With Concurrent
And Sequential Chemoimmunotherapy Using A
Telomerase Vaccine In Locally Advanced And Metastatic
Pancreatic Cancer
III University
of Liverpool
& the Royal
Liverpool and
BILCAP A Randomised Clinical Trial Evaluating Adjuvant
Chemotherapy With Capecitabine Compared To
Expectant Treatment Alone Following Surgery For Biliary
Tract Cancer
III University of
Trials Portfolio
Pending Trials
Acronym Full study title Phase Sponsor
New EPOC A Prospective Randomised Open-Label Trial Of
Exaliplatin/Fluoropyrimidine Versus Oxaliplatin/
Fluoropyrimidine Plus Cetuximab Pre And Post
Operatively In Patients With Resectable Colorectal Liver
Metastasis Requiring Chemotherapy
III South Hampton
ELECT A Randomised Phase II Trial Of Epirubicin, Oxaliplatin And
Capecitabine (EOX) Versus Docetaxel And Oxaliplatin
(EITAX) In The Treatment Of Advanced Gastro-
Oesophageal Cancer
E-Scout A Phase II Study Evaluating The Use Of Concurrent
Cetuximab, Irinotecan, Oxaliplatin And UFT In The First
Line Treatment Of Patients With Metastatic Colorectal
II Christie
SOM2303 A Multi-Centre, Randomised, Blinded Effcacy And Safety
Study Of Pasireotide LAR vs Octreotide LAR In Patients
With Metastatic Carcinoid Tumours Who Disease-Related
Symptoms Are Inadequately Controlled By Somatostatin
III Novartis
ST03 A Randomised Phase II/III trial of Perioperative
Chemotherapy with or without Bevacizumab in
Operable Adenocarcinoma of the Stomach and Gastro-
Oesophageal Junction
RESPECT A Phase II b, Double Blind Randomised Study Evaluating
The Effcacy And Safety Of Sorafenib Compared With
Placebo When Administered In Combination With
Chemotherapy (Modifed FOLFOX6) For The Treatment Of
Metastatic Colorectal Cancer In Subjects Who Have Not
Been Previously Treated For Stage IV Disease
II Bayer
Trans OE02 Prognostic And Predictive Factors In A Randomised
Controlled Clinical Trial Of Pre-Operative Chemotherapy
In Resectable Oesophageal Cancer
Trans MRC
ESPAC T Plus Coding of Samples For Use in Tissue Arrays And For
Storage in Liverpool
Trans University
ESPAC-4 European Study Group for Pancreatic Cancer-Trial 4.
Combination Versus Single Agent Chemotherapy in
Resectable Pancreatic Cancer
III The Royal
Liverpool and
Hospitals NHS
SCOT Short Course Oncology Therapy A Study of Adjuvant
Chemotherapy In Colorectal Cancer
Trials Portfolio
Pending Trials
Acronym Full study title Phase Sponsor
HART Hyperfractionated Accelerated Radiotherapy (HART)
With Chemotherapy (Cisplatin, CCNU, Vincristine) For
Metastatic (M1-3 Medulloblastoma CNS) 2001 06
CONVERT Concurrent Once Daily Versus Twice-Daily Radiotherapy:
A 2-Arm Randomised Controlled Trial Of Concurrent
Chemo-Radiotherapy Comparing Twice-Daily And
Once-Daily Radiotherapy Schedules In Patients With
Limited Stage Small Cell Lung Cancer (SCLC) And Good
Performance Status
III Christie
Hospital NHS
IMPORT LOW Randomised Trial Testing Intensity Modulated And Partial
Organ Radiotherapy Following Breast Conservation
Surgery For Early Breast Cancer
PORTEC-3 PORTEC-3 Randomised Phase III Trial Comparing
Concurrent Chemoradiation and Adjuvant Chemotherapy
witha Pelvic Radiation Alone in High Risk and Advanced
Stage Endometrial Carcinoma
III Leiden
Medical Centre
PET Lung Investigation Of The Use PET-CT Image Fusion In The
Measurement Of Treatment Response In Patients With
Stages IIIB-IV NSCLC Treated With Docetaxel And
Platinum Chemotherapy
IAD A Single Arm Open Phase II Pilot Study On The Effects
Of IAD On Fatigue, Weight loss and Blood Paramaters In
Patients With Malignancies
II Belfast HSC
EPAT Does the institutionalisation of pain assessment using the
EPAT package reduce pain in cancer unit inpatients more
effectively and cost-effectively than usual care and does
it have adverse effects?
III Lothian

PLK 1 A Phase I Study To Determine The Safety
Pharmacokinetics And Pharmacodynamics of GSK
461364, A Polo-Like Kinase 1 (PLK 1) Inhibitor in Adult
Subjects With Advanced Solid Tumour or Non-Hodgkins
Gemin X ES A Phase I Followed By A Randomised Phase II Study Of
Carboplatin And Etoposide With Or Without Obatoclax
Administered Every 3 Weeks To Patients With Extensive
Stage Small Cell Lung Cancer (ES-SCLC)
I Gemin X
ICON 7 A Randomised, Two-Arm, Multi-Centre Gynaecologic
Cancer Intergroup Trial Of Adding Bevacizumab To
Standard Chemotherapy (Carboplatin And Paclitaxel) In
Patients With Epithelial Ovarian Cancer
Trials Portfolio
Pending Trials
Acronym Full study title Phase Sponsor
HART Hyperfractionated Accelerated Radiotherapy (HART)
With Chemotherapy (Cisplatin, CCNU, Vincristine) For
Metastatic (M1-3 Medulloblastoma CNS) 2001 06
CONVERT Concurrent Once Daily Versus Twice-Daily Radiotherapy:
A 2-Arm Randomised Controlled Trial Of Concurrent
Chemo-Radiotherapy Comparing Twice-Daily And
Once-Daily Radiotherapy Schedules In Patients With
Limited Stage Small Cell Lung Cancer (SCLC) And Good
Performance Status
III Christie
Hospital NHS
IMPORT LOW Randomised Trial Testing Intensity Modulated And Partial
Organ Radiotherapy Following Breast Conservation
Surgery For Early Breast Cancer
PORTEC-3 PORTEC-3 Randomised Phase III Trial Comparing
Concurrent Chemoradiation and Adjuvant Chemotherapy
witha Pelvic Radiation Alone in High Risk and Advanced
Stage Endometrial Carcinoma
III Leiden
Medical Centre
PET Lung Investigation Of The Use PET-CT Image Fusion In The
Measurement Of Treatment Response In Patients With
Stages IIIB-IV NSCLC Treated With Docetaxel And
Platinum Chemotherapy
IAD A Single Arm Open Phase II Pilot Study On The Effects
Of IAD On Fatigue, Weight loss and Blood Paramaters In
Patients With Malignancies
II Belfast HSC
EPAT Does the institutionalisation of pain assessment using the
EPAT package reduce pain in cancer unit inpatients more
effectively and cost-effectively than usual care and does
it have adverse effects?
III Lothian

PLK 1 A Phase I Study To Determine The Safety
Pharmacokinetics And Pharmacodynamics of GSK
461364, A Polo-Like Kinase 1 (PLK 1) Inhibitor in Adult
Subjects With Advanced Solid Tumour or Non-Hodgkins
Gemin X ES A Phase I Followed By A Randomised Phase II Study Of
Carboplatin And Etoposide With Or Without Obatoclax
Administered Every 3 Weeks To Patients With Extensive
Stage Small Cell Lung Cancer (ES-SCLC)
I Gemin X
ICON 7 A Randomised, Two-Arm, Multi-Centre Gynaecologic
Cancer Intergroup Trial Of Adding Bevacizumab To
Standard Chemotherapy (Carboplatin And Paclitaxel) In
Patients With Epithelial Ovarian Cancer
Acronym Full study title Phase Sponsor
VCV Vaccine A phase II double-blind randomised placebo-controlled
multi-centre clinical trial to study the safety tolerability
effcacy and immunogenicity of V212/Heat treated
Varicella-Zoster Virus (VCV) Vaccine in recipients of
Autologus hematopoitic cell transplants (HCTs)
II Merck and Co
MMVAR A Randomized Controlled Study Of Velcade (Bortezomib)
Plus Thalidomide Plus Dexamethasone Compared To
Thalidomide Plus Dexamethasone For The Treatment
Of Myeloma Patients Progressing Or Relapsing After
Autologous Transplantation
III European
Group for
blood &
MYELOMA X A Phase III Study To Determine The Role Of A Second
Autologous Stem Cell Transplant As Consolidation
Therapy In Patients With Relapsed Multiple Myeloma
Following Prior High-Dose Chemotherapy And
Autologous Stem Cell Rescue
III Leeds
RGCVP A Phase II Multi-centre Trial of Gemcitabine CVP And
Rituximab (RGCVP) For Treatment of Patients With Early
diagnosed Diffuse Large B Cell Lymphoma Considered
Unsuitable R-CHOP
II University
College London
FIRST A Phase III, Randomised, Open-Label, 3-Arm Study To
Determine The Effcacy And Safety Of Lenalidomide
(Revimid) Plus Low-Dose Dexamethasone When Given
Until Progressive Disease Of For 18 Four-Week Cycles
Versus The Combination Of Melphalan, Prednisone And
Thalidomide Given For 12 Six-Week Cycles In Patients
With Previously Untreated Multiple Myeloma Who Are
Either 65 Years of Age or Older Or not Candidates For
Stem Cell Transplantation (IFM 07-01)
III Celgene
MRD in ALL Minimal Residual Disease Monitoring In Adult Acute
Lymphoblastic Leukaemia, A Laboratory Feasibility Study
Trans Leukaemia
Research Fund
AML 17 A Programme of Treatment Development For Younger
Patients With Acute Myeloid Leukaemia And High Risk
Myelodysplastic Syndrome
III Cardiff
Nilotinib A Phase II Multi Centre, Open-Label, Study Of Nilotinib
At A Dose Of 300mg Twice Daily In Adult Patients With
Newly Diagnosed Philadelphia Chromosome Positive
(PH+) Chronic Myelogenous Leukaemia In Chronic Phase
Trials Portfolio
Pending Trials
Acronym Full study title Phase Sponsor
LUCID A randomised, Open-Label, Multi-Centre Phase II/III
Study to evaluate the safety and effcacy of Lumiliximab
in combination with Fludarabine, Cyclophosphamide
and Rituximab vs Fludarabine, Cyclophosphamide
and Rituximab alone in subjects with relapsed
Chroniclymphatic Leukeamia.
A Randomised Controlled Trial To Evaluate The Effcacy
Of A 6 Month Dietary And Physical Activity Intervention
For Prostate Cancer Survivors Receiving Androgen
Deprivation Therapy
III Queens
University /
Belfast HSC
MK-8669 A Phase II Randomised, Double-Blind, Placebo-Controlled
Clinical Trial To Study The Effcacy And Safety Of
Bicalutamide With Or Without Deforolimus In Men With
Asymptomatic, Metastatic Castrate-Resistant Prostate
II Merck & Co
Selected Publications
n i c c t u
Clamp AR, Schffski P, Valle JW, Wilson RH, Marreaud S,
Govaerts S-A, Debois M, Lacombe D, Twelves C, Chick J, Jayson
GC. (2008) A Phase i and Pharmacokinetic Study of OSi-7904L,
a Liposomal thymidylate Synthase inhibitor in combination with
Oxaliplatin in Patients with Advanced colorectal cancer. Cancer
Chemotherapy and Pharmacology 61 (4): 579-585.
Jones RJ, Hawkins RE, Eatock MM, Ferry DR, Eskens FA, Wilke
H, Evans TR. (2008) A phase ii open-label study of DHA-paclitaxel
(taxoprexin) by 2-h intravenous infusion in previously untreated
patients with locally advanced or metastatic gastric or oesophageal
adenocarcinoma. Cancer Chemother Pharmacol. 61(3): 435-41.
McGarry, C.K., Cosgrove, V.P., Fleming, L.V., OSullivan, J.M.
and Hounsell, A.R. (2008). An Analysis of Geometric uncertainty
calculations for Prostate Radiotherapy in clinical Practice. British
Journal of Radiology 2008, (In Press).
Morris TC, Kettle PJ, Drake M, Jones FC, Hull DR, Boyd K,
Morrison A, Clarke P, OReilly P, Quinn J. (2008) clarithromycin
with low dose dexamethasone and thalidomide is effective therapy in
relapsed/refractory myeloma. Br J Haematol. 143(3):349-54.
Percy MJ, Furlow PW, Lucas GS, Li X, Lappin TRJ, McMullin MF,
Lee FS. (2008)A Gain of Function Mutation in the HiF2A Gene in
Familial Erythrocytosis. N Engl J Med 358(2): 162-168.
Popat R, Oakervee HE, Hallam S, Curry N, Odeh L, Foot
N, Esseltine DL, Drake M, Morris C, Cavenagh JD. (2008)
Bortezomib, doxorubicin and dexamethasone (PAD) front-line
treatment of multiple myeloma: updated results after long-term follow-
up. Br J Haematol. 141(4): 512-6.
Plummer R, Jones C, Middleton M, Wilson RH, Evans J, Curtin
N, Boddy A, Harris A, Johnston PG, Robson L, Steinfeldt H,
Dewji R, Calvert H. (2008) Phase i Study Of the Poly(ADP-Ribose)
Polymerase inhibitor, AG014699, in combination With temozolomide
in Patients with Advanced Solid tumors. Clinical Cancer Research 14
(23): 7917-7923.
Stebbing J, Powles T, McPherson K, Shamash J, Wells P, Sheaff
MT, Slater S, Rudd RM, Fennell D, Steele JP. (2008) the effcacy
and safety of weekly vinorelbine in relapsed malignant pleural
mesothelioma. Lung Cancer. (In Press).
Van Schaeybroeck S, Kelly DM, Kyula J, Stokesberry S, Fennell
DA, Johnston PG, Longley DB. (2008) Src and ADAM-17-mediated
shedding of transforming growth factor-alpha is a mechanism of acute
resistance to tRAiL. Cancer Res. 68(20):8312-21.
Vasey PA, Gore M, Wilson R, Rustin G, Gabra H, Guastalla J-P,
Pujade-Lauraine E, Paul J, Carty K, Kaye S, on behalf of the
Scottish Gynaecological Cancer Trials Group. (2008) A phase ib
trial of Docetaxel, carboplatin and Erlotinib in ovarian, fallopian tube
and primary peritoneal cancers. Br J Cancer. 98 (11): 1774-1780.
Weinkove, R., Reilly, J.T., McMullin, M.F., Curtin, N.J., Radia,
D. and Harrison CN. (2008). Low-dose thalidomide in myelofbrosis.
Haematologica 93(5): 1-2.
Burnett AK, Milligan D, Prentice AG, Goldstone AH, McMullin
MF, Hills RK, Heatley K. (2007)
A comparison of low-dose cytarabine and hydroxyurea with or without
all-transretinoic acid for acute myeloid leukaemia and high risk
myelodysplastic syndrome in patients not considered ft for intensive
treatment. Cancer 109(6): 1114-1124.
Divoli A, Bloch G, Chittenden S, Malaroda A, OSullivan JM,
Dearnaley DP, Flux GD. (2007)
tumour dosimetry on SPEct 186Re-HEDP scans: variations in
the results due to the reconstruction methods used. Cancer Biother.
Radiopharm. 22(1): 121-4.
Fennell DA, Steele JP, Shamash J, Evans MT, Wells P, Sheaff MT,
Rudd RM, Stebbing J. (2007)
Effcacy and safety of frst- or second-line irinotecan, cisplatin, and
mitomycin in mesothelioma. Cancer. 1; 109(1): 93-9.
Fennell DA, Steele JP, Shamash J, Slater SE, Sheaff MT, Wells P,
Rudd RM, Stebbing J. (2007)
Phase ii trial of irinotecan, cisplatin and mitomycin for relapsed small
cell lung cancer. Int J Cancer. 121(11): 2575-7.
James CR, Quinn JE, Mullan PB, Johnston PG, Harkin DP.
(2007) BRcA1, a potential predictive biomarker in the treatment of
breast cancer. Oncologist 12(2): 142-150.
McMullin MF. (2007)
A review of the therapeutic agents in the management of Polycythemia
Vera. Hematological Oncology 25(2): 58-65.
Mitchell DM, McAleese J, Park RM, Stewart DP, Stranex S, Eakin
RL, Houston RF, OSullivan JM. (2007)
Failure to Achieve PSA Level 1ng/ml Following neo-Adjuvant
LHRHa therapy Predicts For A Lower Rate Of Biochemical control
And Lower Overall Survival in Localized Prostate cancer treated
With Radiation therapy. International Journal of Radiation
Oncology, Biology, Physics 69(5): 1467-1471.
Percy MJ, Furlow PW, Lucas GS, Li X, Lappin TRJ, McMullin
MF, Lee FS. (2007)
A Gain of Function Mutation in the HiF2A Gene in Familial
Erythrocytosis. N Engl J Med (In press).
Quinn JE, James CR, Stewart GE, ODonnell JM, Russell SHE,
White P, Chang G, Mullan PB, Johnston PG, Wilson RH, Harkin
DP. (2007)
BRcA1 mRnA Expression Levels Predict for Overall Survival in
Ovarian cancer following chemotherapy. Clinical Cancer Research
13(24): 7413-7420.
Scott LM, Tong W, Levine RL, Scott MA, Beer PA, Stratton MR,
Futeal PA, Erber WA, McMullin MF, Harrison CN, Warren AJ,
Gilliland DG, Lodish HF, Green AR. (2007).
JAK2 exon mutations in Polycythemia Vera and idiopathic
erythrocytosis. New England Journal of Medicine 356(5): 459-468.
Selected Publications
n i c c t u
Selected Publications
n i c c t u
Allen WL, Coyle VM, Johnston PG (2006).
Predicting the outcome of chemotherapy for colorectal cancer. Current
Opinion in Pharmacology 6(4): 332-336.
Bird JM, Fuge R, Sirohi B, Apperley JF, Chapman C, Mahendra
P, Milligan D, Russell N, Littlewood T, Fegan C, McQuaker G,
Pagliuca A, Johnson P, Rahemtulla A, Morris TCM, Marks D.
the clinical outcome and toxicity of high dose chemotherapy and
autologous stem cell transplantation in patients with myeloma and
amyloid and severe renal impairment: a British Society of Blood and
Marrow transplantation Study. British Journal of Haematology;
134(4): 385-90.
Cassidy J, Douillard JY, Twelves C, McKendrick JJ, Scheithauer W,
Bustova I, Johnston PG, Lesniewski-Kmak K, Jelic S, Fountzilas
G, Coxon F, Diaz-Rubio E, Maughan TS, Malzyner A, Bertetto O,
Beham A, Figer A, Dufour P, Patel KK, Cowell W, Garrison LP.
Pharmacoeconomic analysis of adjuvant oral capecitabine vs
intravenous 5-Fu/LV in Dukes c colon cancer: the X-Act trial. Br. J.
Cancer 94(8): 1122-1129.
Clayton A, Mansoor AW, Jones ET, Hawkins RE, Saunders MP,
Swindell R, Valle JW. (2006).
A phase ii study of weekly cisplatin and gemcitabine in patients with
advanced pancreatic cancer: is this a strategy still worth pursuing?
Pancreas 32(1): 51-7.
Falk S, Anthoney A, Eatock M, Van Cutsem E, Chick J, Glen H,
Valle JW, Drolet DW, Albert D, Ferry D, Ajani J. (2006)
A phase ii study of single agent OSi-7904L in patients with
locally advanced or metastatic adenocarcinoma of the stomach or
gastroesophageal junction. British Journal of Cancer 95 (4): 450-6.
OSullivan JM, Norman AR, McCready VR, Flux G, Buffa FM,
Johnson B, Coffey J, Cook G, Treleaven J, Horwich A, Huddart
RA, Parker CC and Dearnaley DP. (2006).
A Phase 2 Study of High Activity Rhenium-186 HEDP with
Autologous Peripheral Blood Stem cell transplant in Progressive
Hormone Refractory Prostate cancer Metastatic to Bone. Eur J Nucl
Med Mol Imaging. 33 (9):1055-1061.
Purcell C, OSullivan JM. (2006).
the role of radioisotopes in the treatment of prostate cancer. Urology
Cancer Abstracts. 25: 2-5.
Stanway SJ, Purohit A, Woo LWL, Suf S, Vigushin D, Ward R,
Wilson RH, Stanczyk FZ, Dobbs N, Kulinskaya E, Elliot M, Potter
BVL, Reed MJ, Coombes RC. (2006)
Phase i study of StX 64 (667 coumate) in breast cancer patients: the
frst study of a steroid sulfatase inhibitor. Clinical Cancer Research 12
(5): 1585-1592.
Vasey PA, Atkinson R, Osborne R, Parkin D, Symonds R, Paul
J, Lewsley L, Coleman R, Reed NS, Kaye S, Rustin GJ. (2006)
ScOtROc 2A: carboplatin followed by docetaxel or docetaxel-
gemcitabine as frst-line chemotherapy for ovarian cancer. Br J Cancer.
94 (1): 62-8.
Wilson RH. (2006)
novel therapeutic developments other than EGFR and VEGF
inhibition in colorectal cancer. The Oncologist; 11 (9): 1018-24.
We gratefully acknowledge the generous
fnancial support of our funders, without
whom our work could not take place. Tese
are the N. Ireland DHSSPS Research and
Development Ofce, Cancer Research UK,
Friends of the Cancer Centre and the Ulster
Cancer Foundation.
We wish to thank our many collaborators
who we do not have space to name in this
document. Tese are health care professionals
from many disciplines and locations within
N. Ireland who actively facilitate, support and
take part in our clinical cancer research.
Most importantly, we are also grateful to our
patients, their families and carers, who give
freely of themselves, their time and energy to
take part in our studies, and to whom our
work is dedicated.

Centre for
Cancer Research
& Cell Biology